Subclinical HypothyroidismNCT00437931
Color Flow Doppler Ultrasound in Subclinical Thyroid Dysfunction
An observational study of Subclinical Hypothyroidism and Hyperthyroidism, run by HaEmek Medical Center, Israel at 1 site in Israel.
Trial summary
Overt hyperthyroidism and hypothyroidism are associated with inverted hemodynamic changes.Regional blood flow disturbances (including intrathyroidal) were also reported in these thyroid disorders. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Subclinical Hypothyroidism, Hyperthyroidism, Thyroid Dysfunction
- How many people
- 60 participants
- Where
- 1 siteIsrael
- Study dates
- Feb 2007to Feb 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with subclinical hypothyroidism and hyperthyroidism
Who may be able to join
- patients with subclinical hypothyroidism or hyperthyroidism
- patients with thyroid nodules and normal thyroid function
Who cannot join
- patients who are taking thyroxine, antithyroid drugs, lithium or amiodarone
- patients who had thyroid surgery or radioiodine therapy
- patients with NYHA class 3 or 4 heart failure
Trial locations and contacts
1 site in 1 country.
About this study
Overt hyperthyroidism and hypothyroidism are associated with inverted hemodynamic changes.Regional blood flow disturbances (including intrathyroidal) were also reported in these thyroid disorders. The purpose of this study is to investigate the thyroid vascularity and blood flow by Color Flow Doppler Sonography in patients with subclinical thyroid dysfunction
Read the detailed description
Color Flow Doppler Sonography (CFDS) has become in the last years an increasing procedure to assess the thyroid blood flow. Previous studies showed specific changes of thyroid blood flow in hyperthyroidism, Hashimoto's thyroiditis and thyroid nodules when investigated by CFDS. Subclinical hyperthyroidism and hypothyroidism are common laboratory findings, defined by normal thyroid hormones concentrations along with ,respectively,decreased or increase Thyroid stimulating hormone (TSH) level. We purpose to investigate thyroid vascularity by CFDS in patients with subclinical hyperthyroidism or hypothyroidism and compared them with euthyroid patients.
- Keywords
- hypothyroidism, hyperthyroidism, thyroid dysfunction, ultrasound, doppler
- Medical subject headings
- Hyperthyroidism, Hypothyroidism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| A | patients with subclinical hypothyroidism | |
| B | patients with subclinical hyperthyroidism | |
| C | patient with normal thyroid function. |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2007 (estimated)
- Study startFeb 2007
- Primary completionFeb 2008
- Study completionFeb 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subclinical HypothyroidismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- HaEmek Medical Center, Israel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, avraham ishay, HaEmek Medical Center, Israel
- Investigators
- Avraham Ishay, MD, Principal investigator, Haemek Medical Center, Endocrine Institute, Afula, IsraelLeonid Chervinsky, Study chair, Haemek Medical Center, Department of Radiology, Afula , IsraelRafael Luboshitzky, MD, Study chair, Haemek Medical Center, Endocrine Institute, Afula, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00437931
- Sponsor's protocol ID
- 006-07-EMC
- Status last verified
- Sep 2016
- First submitted
- 19 Feb 2007
- Last updated
- 8 Sep 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Color Flow Doppler Ultrasound in Subclinical Thyroid Dysfunction
- ClinicalTrials.gov ID
- NCT00437931
- Acronym / sponsor ID
- 006-07-EMC
- Keywords
- hypothyroidism, hyperthyroidism, thyroid dysfunction, ultrasound, doppler
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- HaEmek Medical Center, IsraelUniversity, hospital or other
- Study start
- Feb 2007
- Primary completion
- Feb 2008 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 21 Feb 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Overt hyperthyroidism and hypothyroidism are associated with inverted hemodynamic changes.Regional blood flow disturbances (including intrathyroidal) were also reported in these thyroid disorders. The purpose of this study is to investigate the thyroid vascularity and blood flow by Color Flow Doppler Sonography in patients with subclinical thyroid dysfunction
Detailed description
Color Flow Doppler Sonography (CFDS) has become in the last years an increasing procedure to assess the thyroid blood flow. Previous studies showed specific changes of thyroid blood flow in hyperthyroidism, Hashimoto's thyroiditis and thyroid nodules when investigated by CFDS. Subclinical hyperthyroidism and hypothyroidism are common laboratory findings, defined by normal thyroid hormones concentrations along with ,respectively,decreased or increase Thyroid stimulating hormone (TSH) level. We purpose to investigate thyroid vascularity by CFDS in patients with subclinical hyperthyroidism or hypothyroidism and compared them with euthyroid patients.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A | – | –patients with subclinical hypothyroidism |
| B | – | –patients with subclinical hyperthyroidism |
| C | – | –patient with normal thyroid function. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with subclinical hypothyroidism and hyperthyroidism
Key inclusion criteria (2 listed)
- patients with subclinical hypothyroidism or hyperthyroidism
- patients with thyroid nodules and normal thyroid function
Key exclusion criteria (3 listed)
- patients who are taking thyroxine, antithyroid drugs, lithium or amiodarone
- patients who had thyroid surgery or radioiodine therapy
- patients with NYHA class 3 or 4 heart failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Avraham Ishay, MD principal investigator
Haemek Medical Center, Endocrine Institute, Afula, Israel
Leonid Chervinsky study chair
Haemek Medical Center, Department of Radiology, Afula , Israel
Rafael Luboshitzky, MD study chair
Haemek Medical Center, Endocrine Institute, Afula, Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Subclinical Hypothyroidism and Hyperthyroidism, run by HaEmek Medical Center, Israel at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2016.